Evropska unija - slovenščina - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - brexpiprazole - shizofrenija - psiholeptiki - zdravljenje shizofrenije.

Evropska unija - slovenščina - EMA (European Medicines Agency)

seqirus netherlands b.v. - a/darwin/6/2021(h3n2)-like strain (a/darwin/11/2021, wild type) / a/wisconsin/67/2022 (h1n1)pdm09-like strain (a/georgia/12/2022 cvr-167) / b/austria/1359417/2021-like strain (b/singapore/wuh4618/2021) / b/phuket/3073/2013-like virus (b/singapore/inftt-16-0610/2016, wild type) - gripa, človek - gripi, inaktivirano, split virus ali površinski antigen - prophylaxis of influenza in adults and children from 2 years of age. flucelvax tetra je treba uporabljati v skladu z uradnimi priporočili.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - autologous cd34+ celic, obogaten prebivalstva, ki vsebuje hematopoietic izvornih celic transduced z lentiglobin bb305 lentiviral vektor kodiranje beta-a-t87q-globin gena - beta-talasemija - other hematological agents - zynteglo je indiciran za zdravljenje bolnikov, 12 let in več, s transfuzijo, ki je odvisna β talasemija (tdt), ki nimajo β0/β0 genotip, za katere haematopoietic stem cell (hsc) presaditev, je primerno, ampak človeško leukocyte antigen (hla) ujema povezane hsc donatorjev ni na voljo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - solriamfetol hidroklorid - narcolepsy; sleep apnea, obstructive - psychoanaleptics, - sunosi je pokazala, da izboljšanje budnosti in zmanjšati prekomerno dnevno zaspanost, pri odraslih bolnikih z narcolepsy (z ali brez cataplexy). sunosi je pokazala, da izboljšanje budnosti in zmanjšati prekomerno dnevno zaspanost (eds) pri odraslih bolnikih z obstruktivno spalno apnoea (osa), katerih eds ni bila zadovoljivo zdravljenih s primarno osa terapije, kot so stalno pozitiven tlak v dihalnih poteh (cpap).

Evropska unija - slovenščina - EMA (European Medicines Agency)

seqirus netherlands b.v. - a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227) / a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238) / b/phuket/3073/2013-like strain (b/phuket/3073/2013, bvr-1b) / influenza virus b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26) - gripa, človek - cepiva - profilaksa gripe pri starejših (65 let in starejši). fluad tetra je treba uporabljati v skladu z uradnimi priporočili.

Evropska unija - slovenščina - EMA (European Medicines Agency)

ceva-phylaxia co. ltd. - live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rfp-lt) and avian encephalomyelitis virus, strain calnek 1143 (ae) - immunologicals for aves, live viral vaccines, domestic fowl - piščanec - for active immunisation of chickens of 8 to 13 weeks of age in order to reduce the skin lesions due to fowlpox, to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis and to prevent egg production losses due to avian encephalomyelitis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - cepiva - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Evropska unija - slovenščina - EMA (European Medicines Agency)

ceva santé animale - inactivated fimbrial adhesins of escherichia coli f4ab, inactivated fimbrial adhesins of escherichia coli f4ac, inactivated fimbrial adhesins of escherichia coli f5, inactivated fimbrial adhesins of escherichia coli f6 - imunologija za suidae - prašiči - for the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce clinical signs (severe diarrhoea) and mortality caused by escherichia coli strains expressing the fimbrial adhesins f4ab, f4ac, f5 and f6.

Evropska unija - slovenščina - EMA (European Medicines Agency)

zoetis belgium - bedinvetmab - analgetiki - psi - for the alleviation of pain associated with osteoarthritis in dogs.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - druga zdravila na živčnem sistemu - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.